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Trial record 11 of 141 for:    "Retinitis pigmentosa"

Trial of Oral Valproic Acid for Retinitis Pigmentosa (VPA)

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ClinicalTrials.gov Identifier: NCT01233609
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Foundation Fighting Blindness Clinical Research Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Retinitis Pigmentosa
Interventions: Drug: Valproic Acid
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valproic Acid

Subjects who receive valproic acid

Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)

Placebo

Subjects who receive placebo

Placebo: Dosage per subject weight- same schedule as the active comparator


Participant Flow:   Overall Study
    Valproic Acid   Placebo
STARTED   46   44 
COMPLETED   37   42 
NOT COMPLETED   9   2 
Death                1                0 
Lost to Follow-up                3                1 
Adverse Event                2                1 
Withdrawal by Subject                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Subjects who receive placebo

Placebo: Dosage per subject weight- same schedule as the active comparator

Valproic Acid

Subjects who receive valproic acid

Valproic Acid: One to four 250mg softgels by mouth daily (dose determined by body weight)

Total Total of all reporting groups

Baseline Measures
   Placebo   Valproic Acid   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   46   90 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (10.9)   49.3  (12.3)   50.4  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  45.5%      24  52.2%      44  48.9% 
Male      24  54.5%      22  47.8%      46  51.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      6  13.6%      5  10.9%      11  12.2% 
Not Hispanic or Latino      38  86.4%      41  89.1%      79  87.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   2.2%      1   1.1% 
White      43  97.7%      44  95.7%      87  96.7% 
More than one race      0   0.0%      1   2.2%      1   1.1% 
Unknown or Not Reported      1   2.3%      0   0.0%      1   1.1% 
Genetic Mutations [1] 
[Units: Participants]
Count of Participants
     
RHO   22   19   41 
PRPF31   5   9   14 
RP1   4   9   13 
PRPF8   3   1   4 
PRPH2   2   2   4 
NR2E3   0   2   2 
RHO and PRPH2   2   0   2 
SNRNP200/ASCC3L1   2   0   2 
TOPORS   0   2   2 
IMPDH1   1   0   1 
KLHL7   1   0   1 
NR2E3 and TOPORS   0   1   1 
RHO and ROM1   0   1   1 
[1] Summary of participants' gene mutation or combination of mutations identified and thought to be responsible for autosomal dominant retinitis pigmentosa


  Outcome Measures

1.  Primary:   Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter   [ Time Frame: baseline to week 52 ]

2.  Secondary:   Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter   [ Time Frame: baseline to week 52 ]

3.  Secondary:   Static Perimetry by Treatment Arm--Full Field Hill of Vision   [ Time Frame: baseline to week 52 ]

4.  Secondary:   Static Perimetry Volume--30 Degree Hill of Vision   [ Time Frame: baseline to week 52 ]

5.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity   [ Time Frame: baseline to week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Drug Development Officer
Organization: Foundation Fighting Blindness Clinical Research Institute
phone: 410 423 0581
e-mail: pzilliox@blindness.org


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Foundation Fighting Blindness Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01233609     History of Changes
Other Study ID Numbers: H-13371
First Submitted: November 1, 2010
First Posted: November 3, 2010
Results First Submitted: August 17, 2017
Results First Posted: December 2, 2017
Last Update Posted: December 2, 2017