Trial · NCT01543750
4-Aminopyridine in Episodic Ataxia Type 2
NCT01543750, Phase 2, Withdrawn, University of California, Los Angeles
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 4-Aminopyridine in Episodic Ataxia Type 2. Trials, record NCT01543750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 4-Aminopyridine in Episodic Ataxia Type 2
- NCT number
- NCT01543750
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of California, Los Angeles
- Conditions
- Episodic Ataxia Type 2
- Interventions
- 4-Aminopyridine, Placebo
- First posted
- 2012-03-05
- Last updated
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the frequency of ataxia episodes | 11 months | Trial participants have frequent episodes of ataxia at baseline. The participants will document daily whether ataxia events occurred during the 2-month screening period and the 9-month study period by calling a toll-free number and participating in an Interactive Voice Response (IVR) system. |
| Secondary | impact on daily activities | 11 months | Participants will use IVR to log the impact (on a scale of 0-3) of ataxia events, if any, on their daily activities: * (0) No impact * (1) Mild * (2) Moderate * (3) Severe |
| Secondary | duration of ataxia episodes | 11 months | Study Participants will use IVR daily to log the duration of ataxia events, if any, in hours. |
| Secondary | severity of ataxia episodes | 11 months | Study Participants will use IVR daily to log the severity of ataxia events, if any, on a scale of 1-9: (1) mild (9) very severe |
| Secondary | treatment satisfaction | 9 months | The study participant will respond by phone interview to the 11-item Treatment Satisfaction Questionnaire for Medication (TSQM Version 2) at the end of each of the four treatment periods. |
| Secondary | Toxicity | 9 months | The study participant will be interviewed by phone regarding toxicity using the \[Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0\] at two different time points (4 weeks, 8 weeks) of each 8-week Treatment Period. Spectrum and severity of toxicity and the prevalence among study participants will be documented. |
| Secondary | Side Effects | 9 months | The study participant will log side effects as they occur (reporting the seizures or other severe side effects immediately to Investigators) and will be interviewed by phone regarding side effects at two different time points (4 weeks, 8 weeks) of each 8-week Treatment Period. Spectrum of side effects and the prevalence among those treated will be documented. |
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.
Papers31
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003923 | Phase 2 Study of 4-Aminopyridine for the Treatment of Episodic Ataxia Type 2 | JEN, JOANNA C | UNIVERSITY OF CALIFORNIA LOS ANGELES | FOOD AND DRUG ADMINISTRATION | 2011 |
Source NIH RePORTER
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/NCT01543750
GET https://conductscience.org/api/trials/v1/NCT01543750/papers?page=2