Trial · NCT02844933
Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome
NCT02844933, Phase 2, Terminated, Radius Pharmaceuticals, Inc.; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome. Trials, record NCT02844933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02844933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome
- NCT number
- NCT02844933
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Conditions
- Prader-Willi Syndrome
- Interventions
- Cannabidiol, Placebo
- First posted
- 2016-07-26
- Last updated
- 2023-08-01
- Results first posted
- 2023-08-01
- Limitations and caveats
- This study was prematurely terminated by the previous Sponsor (Insys Therapeutics Inc.). Only 7 participants were enrolled, and the planned number of participants was not achieved.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Baseline, Week 13 | The HQ-CT measures hyperphagia by Prader-Willi syndrome (PWS)-specialized clinicians. The HQ-CT generates a score ranging from 0 to 36, where a higher score represents more severe abnormal food related behaviors. The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline. |
| Secondary | Change From Baseline In Total Body Weight | Baseline, Week 13 | Total body weight refers to participants' weight throughout the study. The change from baseline was calculated from two time points as the value at the later time point minus the value at the earlier time point: value at Week 13 minus value at Baseline. |
| Secondary | Responder Rate From Baseline Through Study Completion | Baseline up to Week 13 | A responder was defined as having a 6 or more points decrease in HQ-CT score. |
| Secondary | Change In Patient Global Impression Of Change (PGI-C) Questionnaire | Week 3, Week 13 | The change in PGI-C scores at Week 3, Week 9, and Week 13 of the participant are evaluated. |
| Secondary | Change From Baseline In The Three Factor Eating Questionnaire - 18-item Version (TFEQ-R18) | Baseline, Week 13 | The change from baseline to Week 13 of the participant's TFEQ-R18 score is evaluated. |
| Secondary | Change From Baseline In Quality Of Life [Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction And Positive Affect Questionnaires] | Baseline, Week 13 | The change from baseline to Week 13 of the participant's quality of life (PROMIS life satisfaction and positive affect questionnaire) score is evaluated. |
| Secondary | Change From Baseline In Physical Activity (PROMIS Physical Activity And Fatigue Questionnaires) | Baseline, Week 13 | The change from baseline to Week 13 of the participant's physical activity (PROMIS physical activity and fatigue questionnaires) score is evaluated. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Baseline, Week 13 | All participants who received at least 1 dose of study drug | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline In Total Body Weight | Baseline, Week 13 | All participants who received at least 1 dose of study drug | kg | MEDIAN |
| SECONDARY | Responder Rate From Baseline Through Study Completion | Baseline up to Week 13 | All participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change In Patient Global Impression Of Change (PGI-C) Questionnaire | Week 3, Week 13 | Due to early study termination, data was not collected for analysis of this outcome measure. | ||
| SECONDARY | Change From Baseline In The Three Factor Eating Questionnaire - 18-item Version (TFEQ-R18) | Baseline, Week 13 | Due to early study termination, data was not collected for analysis of this outcome measure. | ||
| SECONDARY | Change From Baseline In Quality Of Life [Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction And Positive Affect Questionnaires] | Baseline, Week 13 | Due to early study termination, data was not collected for analysis of this outcome measure. | ||
| SECONDARY | Change From Baseline In Physical Activity (PROMIS Physical Activity And Fatigue Questionnaires) | Baseline, Week 13 | Due to early study termination, data was not collected for analysis of this outcome measure. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Cannabidiol | Baseline | 23 | Full Range 10 to 25 | score on a scale |
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Placebo | Baseline | 22 | Full Range 18 to 26 | score on a scale |
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Cannabidiol | Week 13 | 14 | Full Range 7 to 20 | score on a scale |
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Placebo | Week 13 | 16 | Full Range 10 to 28 | score on a scale |
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Cannabidiol | Change from Baseline at Week 13 | -4.5 | Full Range -14 to -3 | score on a scale |
| Change From Baseline in Hyperphagia Behavior as Measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | Placebo | Change from Baseline at Week 13 | -2 | Full Range -12 to 2 | score on a scale |
| Change From Baseline In Total Body Weight | Cannabidiol | Baseline | 88.35 | Full Range 47.9 to 112.4 | kg |
| Change From Baseline In Total Body Weight | Placebo | Baseline | 56.7 | Full Range 45.5 to 109.7 | kg |
| Change From Baseline In Total Body Weight | Cannabidiol | Week 13 | 87.6 | Full Range 47.4 to 110.8 | kg |
| Change From Baseline In Total Body Weight | Placebo | Week 13 | 59.5 | Full Range 46.8 to 109.4 | kg |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cannabidiol | 4 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Cannabidiol | 4 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 3 | |
| Overall Study | COMPLETED | Cannabidiol | 1 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Cannabidiol | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events18
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 | Diarrhea | Gastrointestinal disorders | Cannabidiol | 2 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 3 | |
| other | Rash | Skin and subcutaneous tissue disorders | Cannabidiol | 2 | 4 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 0 | 3 | |
| other | Abdominal cramping | Gastrointestinal disorders | Cannabidiol | 1 | 4 | |
| other | Abdominal cramping | Gastrointestinal disorders | Placebo | 0 | 3 | |
| other | Upper respiratory tract infection | Infections and infestations | Cannabidiol | 1 | 4 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 3 | |
| other | Seizure | Nervous system disorders | Cannabidiol | 0 | 4 | |
| other | Seizure | Nervous system disorders | Placebo | 1 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cannabidiol | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | Cannabidiol | 4 | 4 |
| Total, other adverse events | Placebo | 2 | 3 |
| Total, serious adverse events | Cannabidiol | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cannabidiol vs Placebo: deaths from any cause | Trial comparisons |
| Cannabidiol vs Placebo: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02844933
GET https://conductscience.org/api/trials/v1/NCT02844933/registered