Trial · NCT01911975
Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy
NCT01911975, Phase 3, Completed, Academisch Ziekenhuis Maastricht
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy. Trials, record NCT01911975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01911975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy
- NCT number
- NCT01911975
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Conditions
- Small Fiber Neuropathy
- Interventions
- Lacosamide, Placebo
- First posted
- 2013-07-30
- Last updated
- 2018-01-10
- Other registries' IDs
- eudract:2013-001511-70
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity Numerical Rating Scale | mean daily pain intensity is assesed twice a day, during a period of 33 weeks | |
| Secondary | Daily Sleep Interference Scale | Daily sleep interference will be assesed once daily, during a period of 33 weeks | |
| Secondary | • Adverse Events, Laboratory Safety Tests (Hematology, Clinical Chemistry, Urinalysis), Blood Pressure, Pulse Rate, ECG. | At start of the study and 5 times during 33 weeks | |
| Secondary | Small Fiber Neuropathy Symptoms Inventory Questionnaire (SFN-SIQ). | SFN-SIQ will be assesed 13 times during 33 weeks | |
| Secondary | Patient Global Impression of Change (PGIC). | Global impression of change will be assesed 12 times during 33 weeks | |
| Secondary | Neuropathic Pain Scale (NPS). | Neuropathic pain will be assesed 13 times during 33 weeks. | |
| Secondary | Pain Intensity Numerical Rating Scale | Maximum pain on the pain intensity numerical rating scale will be assesed twice a day during 33 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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
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/NCT01911975
GET https://conductscience.org/api/trials/v1/NCT01911975/registered