Evidence map›Paper›PMID 29637529›Full record

Trial reportCNS drugs2018

ND0701, A Novel Formulation of Apomorphine for Subcutaneous Infusion, in Comparison to a Commercial Apomorphine Formulation: 28-Day Pharmacokinetic Study in Minipigs and a Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Relative Bioavailability.

Yuval Ramot, Abraham Nyska, Liat Adar, Cecile Durlach, Danny Fishelovitch, Giuseppe Sacco, Rosa Anna Manno, Sheila Oren, Itay Perlstein, Oron Yacobi-Zeevi

Abstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. A deep eutectic-based, self-emulsifying subcutaneous depot system for apomorphine therapy in Parkinson's disease.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  6. Review
  7. Review
  8. Review
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Yuval RamotHadassah-Hebrew University Medical Center, Jerusalem, Israel.
Abraham NyskaTel Aviv University, Haharuv 18, PO Box 184, 36576, Timrat, Israel. anyska@bezeqint.net.
Liat AdarNeuroDerm Ltd., Rehovot, Israel.
Cecile DurlachNeuroDerm Ltd., Rehovot, Israel.
Danny FishelovitchNeuroDerm Ltd., Rehovot, Israel.
Giuseppe SaccoResearch Toxicology Centre, Pomezia, Italy.
Rosa Anna MannoResearch Toxicology Centre, Pomezia, Italy.
Sheila OrenNeuroDerm Ltd., Rehovot, Israel.
Itay PerlsteinMagic Wand Research, LLC, Philadelphia, PA, USA.
Oron Yacobi-ZeeviNeuroDerm Ltd., Rehovot, Israel.
NeuroDerm (Israel) · ILHadassah Medical Center · ILTel Aviv University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubcutaneous apomorphine is used for the treatment of Parkinson's disease (PD); however, infusion site reactions are a common adverse event (AE), which can lead to treatment discontinuation. Apomorphine formulations that are more tolerable and convenient for use are needed.

objectiveOur aim was to compare the toxicity and bioavailability of ND0701, a new concentrated formulation of apomorphine free base, with one of the commercially available apomorphine HCl formulations (APO-go

methods(1) Preclinical study: 16 minipigs were randomly assigned to placebo, APO-go

results(1) Preclinical study: No systemic toxicity was observed in apomorphine-treated minipigs, but local skin reactions were observed at the infusion sites. These effects were less frequent and less severe and recovery was more rapid for ND0701 compared with APO-go

conclusionBased on these pilot studies, ND0701 appears to be superior to APO-go

Indexed as

AdultAnimalsApomorphineBiological AvailabilityCross-Over StudiesDopamine AgonistsFemaleHumansInfusions, SubcutaneousMaleMiddle AgedPilot ProjectsRandom AllocationSkinSwineSwine, MiniatureApomorphineDopamine AgonistsND0701

Identifiers

PMID29637529
OpenAlexW2797098568

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.