Trial · NCT03166215
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
NCT03166215, Phase 1, Phase 2, Completed, Takeda; results first posted 2020-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies. Trials, record NCT03166215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03166215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
- NCT number
- NCT03166215
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Developmental and/or Epileptic Encephalopathies
- Interventions
- TAK-935, Placebo
- First posted
- 2017-05-25
- Last updated
- 2026-09-14
- Results first posted
- 2020-01-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment | From first dose up to 30 days post last dose (approximately up to 120 days) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug |
| Secondary | Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | Absorption Rate Constant (Ka) for TAK-935 | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | Cmax,ss: Maximum Observed Plasma Concentration for TAK-935 at Steady State | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | AUC0-tau,ss: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-935 at Steady State | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | Cav,ss: Average Plasma Concentration During a Dosing Interval at Steady State for TAK-935 | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | |
| Secondary | Ctrough,ss: Plasma Concentration Immediately Prior to Dosing for TAK-935 at Steady State | Days 1, 11, 21; Days 31, 41 and 85 pre-dose | |
| Secondary | Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935 | From first dose up to last dose (up to Day 85) | Clinical Laboratory parameters: hematology, serum chemistry and urinalysis. Participants with at least 1 markedly abnormal values during treatment period were reported: Erythrocytes: \<0.8xLLN-\>1.5xULN, Hematocrit: \<0.8x LLN \>1.2xULN,Hemoglobin: \<0.8xLLN-\>1.2xULN Leukocytes: \<0.5xLLN, Platelets (10\^9/L): \<75x10\^9/L-\>600x10\^9/L, Prothrombin Ratio: \>1.5xULN, Alanine Aminotransferase: \>3xULN, Albumin:\<25 g/L, Alkaline Phosphatase: \>3xULN,Alpha-1 Acid Glycoprotein: \<47 mg/DL-\>125 mg/DL, Aspartate Aminotransferase:\>3xULN, Bicarbonate:\<8.0 mmol/L, Calcium:\<1.75 mmol/L-\>2.88 mmol/L, Chloride:\<75 mmol/L-\>126 mmol/L, Cholesterol: \>7.72,Creatine Kinase:\>5xULN, Creatinine:\>177 umol/L, Gamma Glutamyl Transferase: \>3xULN, Glucose:\<2.8 mmol/L- \>19.4 mmol/L,HDL Cholesterol: \<1.04 mmol/L-\>1.55 mmol/L, LDL Cholesterol: \<1.30 mmol/L-\>4.14 mmol/L, Potassium:\<3.0 mmol/L-\>6.0 mEq/L, Protein:\<0.8xLLN-\>1.2 x ULN, Sodium: \<130 mmol/L-\>150 mmol/L, Triglycerides: \>2.5xULN, Urea Nitrogen: \>10.7 mmol/L. |
| Secondary | Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935 | From first dose up to 30 days post last dose (approximately up 120 days) | Vital signs included heart rate, blood pressure and body temperature. markedly abnormal values during treatment period were categorized as: heart rate 1,3 and 5 min standing (beats/min) \<50-\>120, systolic blood pressure 1,3 and 5 min standing (mmHg) \<85-\>180, diastolic blood pressure 1,3 and 5 min standing (mmHg) \<50-\>110 and body temperature (degree centigrade) \<35.6- \>37.7. Only categories with values have been reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment | From first dose up to 30 days post last dose (approximately up to 120 days) | Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | Pharmacokinetic (PK) Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or metabolite of TAK-935 (M-I) plasma concentration. | L/hr | MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | L | MEAN |
| SECONDARY | Absorption Rate Constant (Ka) for TAK-935 | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | 1/hr | MEAN |
| SECONDARY | Cmax,ss: Maximum Observed Plasma Concentration for TAK-935 at Steady State | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | ng/mL | MEAN |
| SECONDARY | AUC0-tau,ss: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-935 at Steady State | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | ng*hr/mL | MEAN |
| SECONDARY | Cav,ss: Average Plasma Concentration During a Dosing Interval at Steady State for TAK-935 | Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | ng/mL | MEAN |
| SECONDARY | Ctrough,ss: Plasma Concentration Immediately Prior to Dosing for TAK-935 at Steady State | Days 1, 11, 21; Days 31, 41 and 85 pre-dose | PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935 | From first dose up to last dose (up to Day 85) | Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935 | From first dose up to 30 days post last dose (approximately up 120 days) | Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment | Part 1: Placebo | 100 | percentage of participants | ||
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment | Part 1: TAK-935 | 71.4 | percentage of participants | ||
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment | Part 2: TAK-935 | 68.8 | percentage of participants | ||
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 100 mg BID | CL | 259.4 | Standard Deviation 148.1 | L/hr |
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 200 mg BID | CL | 195.8 | Standard Deviation 116.3 | L/hr |
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 300 mg BID | CL | 190 | Standard Deviation 108.5 | L/hr |
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 100 mg BID | Q | 100.6 | Standard Deviation 22.24 | L/hr |
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 200 mg BID | Q | 70.99 | Standard Deviation 14.6 | L/hr |
| Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 300 mg BID | Q | 57.77 | Standard Deviation 11.36 | L/hr |
| Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration | TAK-935 100 mg BID | Vc | 56.59 | Standard Deviation 22.72 | L |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Double-blind TP: Days 1 - 30) | STARTED | Part 1: Placebo | 4 | |
| Part 1 (Double-blind TP: Days 1 - 30) | STARTED | Part 1: TAK-935 | 14 | |
| Part 1 (Double-blind TP: Days 1 - 30) | STARTED | Part 2: TAK-935 | 0 | |
| Part 1 (Double-blind TP: Days 1 - 30) | COMPLETED | Part 1: Placebo | 4 | |
| Part 1 (Double-blind TP: Days 1 - 30) | COMPLETED | Part 1: TAK-935 | 12 | |
| Part 1 (Double-blind TP: Days 1 - 30) | COMPLETED | Part 2: TAK-935 | 0 | |
| Part 1 (Double-blind TP: Days 1 - 30) | NOT COMPLETED | Part 1: Placebo | 0 | |
| Part 1 (Double-blind TP: Days 1 - 30) | NOT COMPLETED | Part 1: TAK-935 | 2 | |
| Part 1 (Double-blind TP: Days 1 - 30) | NOT COMPLETED | Part 2: TAK-935 | 0 | |
| Part 2 (Open-Label TP: Days 31 - 85) | STARTED | Part 1: Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Part 1: Placebo | 0 | 4 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 1: TAK-935 | 2 | 14 | |
| other | Upper respiratory tract infection | Infections and infestations | Part 2: TAK-935 | 1 | 16 | |
| other | Bronchitis | Infections and infestations | Part 1: Placebo | 0 | 4 | |
| other | Bronchitis | Infections and infestations | Part 1: TAK-935 | 0 | 14 | |
| other | Bronchitis | Infections and infestations | Part 2: TAK-935 | 1 | 16 | |
| other | Ear infection | Infections and infestations | Part 1: Placebo | 0 | 4 | |
| other | Ear infection | Infections and infestations | Part 1: TAK-935 | 0 | 14 | |
| other | Ear infection | Infections and infestations | Part 2: TAK-935 | 1 | 16 | |
| other | Influenza | Infections and infestations | Part 1: Placebo | 0 | 4 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Placebo | 0 | 4 |
| Total, all-cause mortality | Part 1: TAK-935 | 0 | 14 |
| Total, all-cause mortality | Part 2: TAK-935 | 0 | 16 |
| Total, other adverse events | Part 1: Placebo | 4 | 4 |
| Total, other adverse events | Part 1: TAK-935 | 10 | 14 |
| Total, other adverse events | Part 2: TAK-935 | 11 | 16 |
| Total, serious adverse events | Part 1: Placebo | 0 | 4 |
| Total, serious adverse events | Part 1: TAK-935 | 1 | 14 |
| Total, serious adverse events | Part 2: TAK-935 | 3 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33940389 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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