Spinal Cord InjuriesPhase 3NCT03899584

High Doses of 4-aminopyridine in Clinically Complete Chronic Spinal Cord Injury Patients.

A Phase 3 study testing 4-Aminopyridine in people with Spinal Cord Injuries and Chronic, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Spinal Cord Injuries, Chronic
What is being tested?: 4-Aminopyridine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteMexico
Study dates: 17 Jul 2019to Dec 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

None listed.

Who cannot join

Pressure ulcers, skin infections, or phlebitis
History of cardiovascular disease (syncope, arrhythmia, or myocardial infarction within the last two years), systolic blood pressure greater than 150 or less than 70 mm Hg, diastolic blood pressure greater than 110 or less than 50 mm Hg, or heart rate greater than 110 or less than 50 beats/minute; impaired hepatic function (total hepatic enzyme or bilirubin levels greater than 2 times the upper limits of normal) or impaired renal function (creatinine level greater than 2 times the upper limits of normal) less than 6 months before the study
Know allergy to pyridine-containing drugs
Neurologic, degenerative, or psychiatric disorders that would impair the patient's ability to complete the protocol
Any illness or abnormality that would jeopardize patient safety or interfere with the conduct of the study
Inability to discontinue excluded concomitant drug therapy

Show all 13Show fewer

Were pregnant or lactating
Had received any other investigational drug less tan 30 days before the study
History of drug or alcohol abuse
Treatment with and anti-spasticity compound and could not maintain a stable daily dosage
Had received any drug known to cause significant major organ toxicity less tan 3 months before the study
Peripheral neuropathy
Treatment with corticosteroids

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital de Especialidades, CMN Siglo XXI
Mexico City, 06725

Other trials in Mexico

About this study

Official title: Quality of Life, Efficacy and Safety of High Doses of 4-aminopyridine in Patients With Clinically Complete Chronic Spinal Cord Injury: Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Trial

150 patients with clinically complete chronic spinal cord Injury will be included in a randomized, parallel, placebo controlled, multi-centric, phase III trial. Patients will be evaluated before starting the medication, and at the end of the treatment in the locomotor, sensory, grade of independence, sensitivity and control of bladder and anal sphincters, quality of life, and psychogenic erection in males. Patients will be divided randomly into two groups where one will receive placebo and the other one 4-Aminopyridine (4-AP) in a maximum of 30 weeks in increasing doses.

Read the detailed description

Consecutive patients with chronic AIS A tetraplegic or paraplegic with an MRI showing cord continuity will be recruited in the departments of neurology, neurosurgery or rehabilitation from hospitals of Social Security Mexican Institute (IMSS) in 8 states . Just patients who meeting inclusion criteria, will be selected for the study until reach 150. After signing an informed consent, they will be randomized into 75 for the intervention arm and 75 for the placebo arm. All patients will receive capsules for daily consumption according to their assignment. They will receive ascending doses of the drug starting with 10 milligrams and progressively increasing every 2 to 4 weeks 10 mg until reaching the maximum dose proposed according to weight (maximum 1 mg/kg/d). Questionnaires and functional evaluations will be administered at the beginning of the study, and at the end of the treatment to evaluate the efficacy. The evaluations include the International Standards for Neurological Classification of Spinal Cord Injury motor and sensory Scale, the Spinal Cord Injury Independence Measure (SCIM III), quality of life (SF-36), sphincter bladder/anal sensation/control in both genders and psychogenic erection in males as primary outcomes.

After the follow-up period, all test results will be analyzed and compared to determine the efficacy and safety of 4-aminopyridine. The Mann-Whitney U and Chi-square test will be used for statistical analysis.

Conditions: Spinal Cord Injuries, Chronic
Being tested: 4-Aminopyridine, Placebo oral capsule
Keywords: 4-Aminopyridine, erectile function, tetraplegia, rehabilitation, questionnaires, paraplegia
Medical subject headings: Spinal Cord Injuries, Bronchiolitis Obliterans Syndrome, Quadriplegia, Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4-AminopyridineDrug
Also called 4-AP
Each patient will take 10 mg per kilogram of weight (example: a person weighing 60 kg, will take two capsules three times a day after meals, for a total of 6 capsules / day). Each capsule will contain 10 milligrams of 4-Aminopyridine that will allow to be administered sequentially at progressively higher doses / day. The dose of 4-aminopyridine will increase 10 mg / 2 to 4 weeks.
Placebo oral capsuleDrug
Also called Microcrystalline cellulose
The placebo arm will include a placebo of microcrystalline cellulose.

Study groups in NCT03899584
Study group	Role	What they receive
Treatment with 4-aminopyridine	Active comparator	The 4-aminopyridine will be administered in the form of gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as excipient. The dose of 4-aminopyridine will increase 10 mg / every 2 to 4 weeks until reaching the maximum dose proposed by weight ( maximum 1 mg / kg / d). Receives: Drug: 4-Aminopyridine
Placebo oral capsule	Placebo comparator	Patients randomized to the placebo sequence will receive placebo in the same way as those who will take 4-AP. They will be blinded to the fact that they are taking placebo and the capsules will be identical in appearance to the intervention capsules. Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Sensory Function
This function will be examined using the ASIA International Standards for the Neurological and Functional Classification of Spinal Cord Injury. Sensory function will be evaluated and qualify for two modes, pin prick / light touch in all dermatomes. The first one will be measured with the sharp and blunt end of a safety pin and the last one will be evaluated with a cotton ball. A scale of 3 points (0- 2) will be used depending on whether the modality is normal (2), diminished (1) or absent (0). A score of 2 for each of the 28 key sensory points tested on each side of the body would result in a maximum score of 56 for pin prick, 56 for light touch, and a total of 112, higher values represent a better outcome.
Measured: From baseline at 6 months after treatment
Changes in Motor function
Motor function will be examined using the ASIA International Standards for the Neurological and Functional Classification of Spinal Cord Injury. Muscle strength will be evaluated in each of the 20 key muscles, five in each limb, representing segments of the spinal cord C5 through T1 and L2 through S1, using a six-point rating scale (0-5). There is a maximum score of 25 for each extremity, totaling 50 for the upper limbs and 50 for the lower limbs. Changes in motor score (total range from 0 to 100, higher values represent a better outcome).
Measured: From baseline at 6 months after treatment
Changes in the functional assement of Spinal Cord Independence
The Spinal Cord Independence Measure version III (SCIM III) has 16 questions on self-care, respiratory and sphincter management and mobility in and out of home, which ranges from 0 (total dependence) to 100 points (total Independence).
Measured: From baseline at 6 months after treatment
Changes in the Sphincters function
The function of the anal sphincter and the bladder will be evaluated. The anal function will be qualified as a sensation when the patient can differentiate when the rectum is full and ready to empty and control when the patient can stop the fecal evacuation with enough time to reach the bathroom and eliminate the fecal material. The function of the bladder will be classified in the same way as the anal function. Positive or negative will be the final result of sensation and control.
Measured: From baseline at 6 months after treatment
Change of overall quality of life score as measured by Short Form-36 (SF-36)
The Short Form-36 (SF-36) has 36 questions. Each question has a score, which will be transformed into a 0 to 100 scale, where 0 corresponds to "the worst health state" and 100 to "the best health state".
Measured: From baseline at 6 months after treatment
Changes in Mean International Index of Erectile Function
The international Index of Erectile Function (IIEF) contains 15 questions, rated from 0 or 1 to 5, yielding an overall score of 5-75 points. A score of 1-10 indicates severe erectile dysfunction, 11-16 moderate dysfunction, 17-25 mild dysfunction, and greater than 25 "normal" function.
Measured: From baseline at 6 months after treatment
Incidence of Treatment-Emergent Adverse Events (Safety)
Safety will be measured by occurrence of Treatment-Emergent Adverse Events (TRAEs); data will represent the number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 2019Dec 2023

First posted2 Apr 2019
Study start17 Jul 2019
Primary completionDec 2022 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03899584
Sponsor's protocol ID: 2010-785-073
Status last verified: Feb 2021
First submitted: 13 Feb 2019
Last updated: 21 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hansebout RR, Blight AR, Fawcett S, Reddy K. 4-Aminopyridine in chronic spinal cord injury: a controlled, double-blind, crossover study in eight patients. J Neurotrauma. 1993 Spring;10(1):1-18. doi: 10.1089/neu.1993.10.1.
PubMed 8320728
Waxman SG. Aminopyridines and the treatment of spinal cord injury. J Neurotrauma. 1993 Spring;10(1):19-24. doi: 10.1089/neu.1993.10.19. No abstract available.
PubMed 8320729
Hayes KC, Blight AR, Potter PJ, Allatt RD, Hsieh JT, Wolfe DL, Lam S, Hamilton JT. Preclinical trial of 4-aminopyridine in patients with chronic spinal cord injury. Paraplegia. 1993 Apr;31(4):216-24. doi: 10.1038/sc.1993.40.
PubMed 8493036
Hayes KC, Potter PJ, Wolfe DL, Hsieh JT, Delaney GA, Blight AR. 4-Aminopyridine-sensitive neurologic deficits in patients with spinal cord injury. J Neurotrauma. 1994 Aug;11(4):433-46. doi: 10.1089/neu.1994.11.433.
PubMed 7837283
Zeidman SM, Ling GS, Ducker TB, Ellenbogen RG. Clinical applications of pharmacologic therapies for spinal cord injury. J Spinal Disord. 1996 Oct;9(5):367-80.
PubMed 8938604
Potter PJ, Hayes KC, Hsieh JT, Delaney GA, Segal JL. Sustained improvements in neurological function in spinal cord injured patients treated with oral 4-aminopyridine: three cases. Spinal Cord. 1998 Mar;36(3):147-55. doi: 10.1038/sj.sc.3100559.
PubMed 9554012
Hayes KC. 4-Aminopyridine and spinal cord injury: a review. Restor Neurol Neurosci. 1994 Jan 1;6(4):259-70. doi: 10.3233/RNN-1994-6401.
PubMed 21551756
Donovan WH, Halter JA, Graves DE, Blight AR, Calvillo O, McCann MT, Sherwood AM, Castillo T, Parsons KC, Strayer JR. Intravenous infusion of 4-AP in chronic spinal cord injured subjects. Spinal Cord. 2000 Jan;38(1):7-15. doi: 10.1038/sj.sc.3100931.
PubMed 10762192
van der Bruggen MA, Huisman HB, Beckerman H, Bertelsmann FW, Polman CH, Lankhorst GJ. Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury. J Neurol. 2001 Aug;248(8):665-71. doi: 10.1007/s004150170111.
PubMed 11569894
Wolfe DL, Hayes KC, Hsieh JT, Potter PJ. Effects of 4-aminopyridine on motor evoked potentials in patients with spinal cord injury: a double-blinded, placebo-controlled crossover trial. J Neurotrauma. 2001 Aug;18(8):757-71. doi: 10.1089/089771501316919120.
PubMed 11526982
Grijalva I, Guizar-Sahagun G, Castaneda-Hernandez G, Mino D, Maldonado-Julian H, Vidal-Cantu G, Ibarra A, Serra O, Salgado-Ceballos H, Arenas-Hernandez R. Efficacy and safety of 4-aminopyridine in patients with long-term spinal cord injury: a randomized, double-blind, placebo-controlled trial. Pharmacotherapy. 2003 Jul;23(7):823-34. doi: 10.1592/phco.23.7.823.32731.
PubMed 12885095
Hayes KC, Potter PJ, Hsieh JT, Katz MA, Blight AR, Cohen R. Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (Fampridine-SR) in subjects with chronic, incomplete spinal cord injury. Arch Phys Med Rehabil. 2004 Jan;85(1):29-34. doi: 10.1016/s0003-9993(03)00651-8.
PubMed 14970964
DeForge D, Nymark J, Lemaire E, Gardner S, Hunt M, Martel L, Curran D, Barbeau H. Effect of 4-aminopyridine on gait in ambulatory spinal cord injuries: a double-blind, placebo-controlled, crossover trial. Spinal Cord. 2004 Dec;42(12):674-85. doi: 10.1038/sj.sc.3101653.
PubMed 15356676
Cardenas DD, Ditunno J, Graziani V, Jackson AB, Lammertse D, Potter P, Sipski M, Cohen R, Blight AR. Phase 2 trial of sustained-release fampridine in chronic spinal cord injury. Spinal Cord. 2007 Feb;45(2):158-68. doi: 10.1038/sj.sc.3101947. Epub 2006 Jun 13.
PubMed 16773037
Grijalva I, Garcia-Perez A, Diaz J, Aguilar S, Mino D, Santiago-Rodriguez E, Guizar-Sahagun G, Castaneda-Hernandez G, Maldonado-Julian H, Madrazo I. High doses of 4-aminopyridine improve functionality in chronic complete spinal cord injury patients with MRI evidence of cord continuity. Arch Med Res. 2010 Oct;41(7):567-75. doi: 10.1016/j.arcmed.2010.10.001.
PubMed 21167397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality of Life, Efficacy and Safety of High Doses of 4-aminopyridine in Patients With Clinically Complete Chronic Spinal Cord Injury: Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03899584
Acronym / sponsor ID: 2010-785-073
Conditions: Spinal Cord Injuries, Chronic
Keywords: 4-Aminopyridine, erectile function, tetraplegia, rehabilitation, questionnaires, paraplegia
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (actual)
Lead sponsor: Coordinación de Investigación en Salud, MexicoOther government
Study start: 17 Jul 2019 (actual)
Primary completion: Dec 2022 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 2 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment with 4-aminopyridine	Active comparator	Drug: 4-AminopyridineThe 4-aminopyridine will be administered in the form of gelatin capsules containing 4-aminopyridine 10 mg and microcrystalline cellulose as excipient. The dose of 4-aminopyridine will increase 10 mg / every 2 to 4 weeks until reaching the maximum dose proposed by weight ( maximum 1 mg / kg / d).
Placebo oral capsule	Placebo comparator	Drug: Placebo oral capsulePatients randomized to the placebo sequence will receive placebo in the same way as those who will take 4-AP. They will be blinded to the fact that they are taking placebo and the capsules will be identical in appearance to the intervention capsules.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (13 listed)

Pressure ulcers, skin infections, or phlebitis
History of cardiovascular disease (syncope, arrhythmia, or myocardial infarction within the last two years), systolic blood pressure greater than 150 or less than 70 mm Hg, diastolic blood pressure greater than 110 or less than 50 mm Hg, or heart rate greater than 110 or less than 50 beats/minute; impaired hepatic function (total hepatic enzyme or bilirubin levels greater than 2 times the upper limits of normal) or impaired renal function (creatinine level greater than 2 times the upper limits of normal) less than 6 months before the study
Know allergy to pyridine-containing drugs
Neurologic, degenerative, or psychiatric disorders that would impair the patient's ability to complete the protocol
Any illness or abnormality that would jeopardize patient safety or interfere with the conduct of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
4-AminopyridineAlso: 4-APEach patient will take 10 mg per kilogram of weight (example: a person weighing 60 kg, will take two capsules three times a day after meals, for a total of 6 capsules / day). Each capsule will contain 10 milligrams of 4-Aminopyridine that will allow to be administered sequentially at progressively higher doses / day. The dose of 4-aminopyridine will increase 10 mg / 2 to 4 weeks.	Drug	Treatment with 4-aminopyridine
Placebo oral capsuleAlso: Microcrystalline celluloseThe placebo arm will include a placebo of microcrystalline cellulose.	Drug	Placebo oral capsule

Primary outcome

Changes in Sensory Function
Time frame: From baseline at 6 months after treatment
This function will be examined using the ASIA International Standards for the Neurological and Functional Classification of Spinal Cord Injury. Sensory function will be evaluated and qualify for two modes, pin prick / light touch in all dermatomes. The first one will be measured with the sharp and blunt end of a safety pin and the last one will be evaluated with a cotton ball. A scale of 3 points (0- 2) will be used depending on whether the modality is normal (2), diminished (1) or absent (0). A score of 2 for each of the 28 key sensory points tested on each side of the body would result in a maximum score of 56 for pin prick, 56 for light touch, and a total of 112, higher values represent a better outcome.
Changes in Motor function
Time frame: From baseline at 6 months after treatment
Motor function will be examined using the ASIA International Standards for the Neurological and Functional Classification of Spinal Cord Injury. Muscle strength will be evaluated in each of the 20 key muscles, five in each limb, representing segments of the spinal cord C5 through T1 and L2 through S1, using a six-point rating scale (0-5). There is a maximum score of 25 for each extremity, totaling 50 for the upper limbs and 50 for the lower limbs. Changes in motor score (total range from 0 to 100, higher values represent a better outcome).
Changes in the functional assement of Spinal Cord Independence
Time frame: From baseline at 6 months after treatment
The Spinal Cord Independence Measure version III (SCIM III) has 16 questions on self-care, respiratory and sphincter management and mobility in and out of home, which ranges from 0 (total dependence) to 100 points (total Independence).
Changes in the Sphincters function
Time frame: From baseline at 6 months after treatment
The function of the anal sphincter and the bladder will be evaluated. The anal function will be qualified as a sensation when the patient can differentiate when the rectum is full and ready to empty and control when the patient can stop the fecal evacuation with enough time to reach the bathroom and eliminate the fecal material. The function of the bladder will be classified in the same way as the anal function. Positive or negative will be the final result of sensation and control.
Change of overall quality of life score as measured by Short Form-36 (SF-36)
Time frame: From baseline at 6 months after treatment
The Short Form-36 (SF-36) has 36 questions. Each question has a score, which will be transformed into a 0 to 100 scale, where 0 corresponds to "the worst health state" and 100 to "the best health state".
Changes in Mean International Index of Erectile Function
Time frame: From baseline at 6 months after treatment
The international Index of Erectile Function (IIEF) contains 15 questions, rated from 0 or 1 to 5, yielding an overall score of 5-75 points. A score of 1-10 indicates severe erectile dysfunction, 11-16 moderate dysfunction, 17-25 mild dysfunction, and greater than 25 "normal" function.
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: 6 months
Safety will be measured by occurrence of Treatment-Emergent Adverse Events (TRAEs); data will represent the number of participants with abnormal laboratory values and/or adverse events that are related to treatment.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Background: PubMed 8320728Hansebout RR, Blight AR, Fawcett S, Reddy K. 4-Aminopyridine in chronic spinal cord injury: a controlled, double-blind, crossover study in eight patients. J Neurotrauma. 1993 Spring;10(1):1-18. doi: 10.1089/neu.1993.10.1.
Background: PubMed 8320729Waxman SG. Aminopyridines and the treatment of spinal cord injury. J Neurotrauma. 1993 Spring;10(1):19-24. doi: 10.1089/neu.1993.10.19. No abstract available.
Background: PubMed 8493036Hayes KC, Blight AR, Potter PJ, Allatt RD, Hsieh JT, Wolfe DL, Lam S, Hamilton JT. Preclinical trial of 4-aminopyridine in patients with chronic spinal cord injury. Paraplegia. 1993 Apr;31(4):216-24. doi: 10.1038/sc.1993.40.
Background: PubMed 7837283Hayes KC, Potter PJ, Wolfe DL, Hsieh JT, Delaney GA, Blight AR. 4-Aminopyridine-sensitive neurologic deficits in patients with spinal cord injury. J Neurotrauma. 1994 Aug;11(4):433-46. doi: 10.1089/neu.1994.11.433.
Background: PubMed 8938604Zeidman SM, Ling GS, Ducker TB, Ellenbogen RG. Clinical applications of pharmacologic therapies for spinal cord injury. J Spinal Disord. 1996 Oct;9(5):367-80.
Background: PubMed 9554012Potter PJ, Hayes KC, Hsieh JT, Delaney GA, Segal JL. Sustained improvements in neurological function in spinal cord injured patients treated with oral 4-aminopyridine: three cases. Spinal Cord. 1998 Mar;36(3):147-55. doi: 10.1038/sj.sc.3100559.
Background: PubMed 21551756Hayes KC. 4-Aminopyridine and spinal cord injury: a review. Restor Neurol Neurosci. 1994 Jan 1;6(4):259-70. doi: 10.3233/RNN-1994-6401.
Background: PubMed 10762192Donovan WH, Halter JA, Graves DE, Blight AR, Calvillo O, McCann MT, Sherwood AM, Castillo T, Parsons KC, Strayer JR. Intravenous infusion of 4-AP in chronic spinal cord injured subjects. Spinal Cord. 2000 Jan;38(1):7-15. doi: 10.1038/sj.sc.3100931.
Background: PubMed 11569894van der Bruggen MA, Huisman HB, Beckerman H, Bertelsmann FW, Polman CH, Lankhorst GJ. Randomized trial of 4-aminopyridine in patients with chronic incomplete spinal cord injury. J Neurol. 2001 Aug;248(8):665-71. doi: 10.1007/s004150170111.
Background: PubMed 11526982Wolfe DL, Hayes KC, Hsieh JT, Potter PJ. Effects of 4-aminopyridine on motor evoked potentials in patients with spinal cord injury: a double-blinded, placebo-controlled crossover trial. J Neurotrauma. 2001 Aug;18(8):757-71. doi: 10.1089/089771501316919120.
Background: PubMed 12885095Grijalva I, Guizar-Sahagun G, Castaneda-Hernandez G, Mino D, Maldonado-Julian H, Vidal-Cantu G, Ibarra A, Serra O, Salgado-Ceballos H, Arenas-Hernandez R. Efficacy and safety of 4-aminopyridine in patients with long-term spinal cord injury: a randomized, double-blind, placebo-controlled trial. Pharmacotherapy. 2003 Jul;23(7):823-34. doi: 10.1592/phco.23.7.823.32731.
Background: PubMed 14970964Hayes KC, Potter PJ, Hsieh JT, Katz MA, Blight AR, Cohen R. Pharmacokinetics and safety of multiple oral doses of sustained-release 4-aminopyridine (Fampridine-SR) in subjects with chronic, incomplete spinal cord injury. Arch Phys Med Rehabil. 2004 Jan;85(1):29-34. doi: 10.1016/s0003-9993(03)00651-8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martín Paredes Cruz, MSc principal investigator

Instituto Mexicano del Seguro Social

Israel Grijalva Otero, PhD study director

Instituto Mexicano del Seguro Social

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4-Aminopyridine in people with Spinal Cord Injuries and Chronic, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Sensory Function (time frame: From baseline at 6 months after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899584, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.